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The International Coordinating Committee for the Registration of Technical Standards for Human Drugs (ICH) put forward the QbD concept (quality comes from the design concept) in the ICH Q8(R2) issued in 2009, and its main goal is consistent drug product quality or performance and subsequent cost reduce. The application of QbD concept in formulation designRead more

When taking sustained-release drugs, the drugs will slowly be released into the blood and provide help within a certain period of time. Tragedy can occur when the drug dissolves too slowly or too quickly. For example, OxyContin, which contains Oxycodone (the opioid family), normally provides 12 hours of pain relief, but in some patients itRead more

On April 2, Zhou Xiaotang, senior director of Medicilon’s preparation department, shared with us the formulation research strategy of innovative drugs. The content of the course is condensed below for everyone and displayed in the form of question and answer. 1. What regulations need to be paid attention to in the pharmaceutical research of innovativeRead more